Adaptation and Validation of the Arabic Version of EuroQol 5D-5L

Cross Cultural Adaptation and Validation of The Arabic Version Of EuroQol 5D-5L

The aim of the work is to provide a validated Arabic version of EuroQol 5D-5L ,so that it would be used as a quality of life assessment tool for Egyptian patients

Specific objectives:

1. Cross cultural adaptation of the translated Arabic version of EuroQol 5D-5L.
2. Assessment of the reliability of the translated Arabic version of EuroQol 5D-5L.
3. Testing the validity of the translated version of EuroQol 5D-5L.

Study Overview

• Status: Unknown
• Conditions: Validation Study
• Intervention / Treatment: Other: questionnaire

Detailed Description

Chronic back pain is one of the most important disabling illnesses. It has a high incidence, high prevalence and high cost to society. One of the most common causes of back pain are degenerative spine diseases which affect all aspects of quality of life (QoL) of the patients. They could affect job opportunities, social activities and hinder the patients from performing common daily activities.It was found that many factors could affect quality of life of spine degenerative diseases patients such as sex, age, body mass index (BMI), employment status , living with other family members, smoking, orthopedic disorder in another part of the body (other than spinal disease), history of spinal surgery, and bladder function. Comprehensive assessment of these patients should include health related quality of life (HRQoL) measures in addition to the objective clinical measures of the diseases. Europeans Quality of life questionnaire 5 dimensions ,5 levels (EQ-5D-5L) is a standardized measure of health status developed by the EuroQol Group which provides a simple, generic measure of health for clinical and economic appraisal (2).Despite being translated and validated in many languages, there is no validated Arabic version of EQ-5D-5L to measure the quality of life. The objective of this study is to evaluate the reliability and validity of the Arabic version of the questionnaire for Egyptian patients diagnosed to have Spine degenerative diseases.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Ahmed Mahmoud Ahmed; Phone Number: +201024608017; Email: drahmed.mahmoud@yahoo.com
• Study Contact Backup: Name: Ahmed Shawky Abdelgawaad, Dr; Phone Number: +20100212222; Email: ahsh313@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

between 18 and 70 years old. patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics.

Description

Inclusion Criteria:

• patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics.

Exclusion Criteria:

• preoperative patients and immediate postoperative patients.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A reliable and validated Arabic version of the EQ-5D-5L instrument	Cross cultural adaptation and validation of the Arabic version of the EQ-5D-5L.	basline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
factors affecting quality of life of spine disease patients.	to study factors affecting quality of life of spine disease patients.	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
• Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: validation of EuroQol 5D-5L

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No